Multivitamins During Pregnancy and After Birth Delay Progression of HIV In Women

Multivitamin supplements containing high doses of the vitamin
B complex, as well as vitamins C and E, given to HIV-infected women
during pregnancy and for more than 5 years after they gave birth
reduced the symptoms of AIDS, according to a study of Tanzanian
women supported by the National Institute of Child Health and Human
Development (NICHD) and the John E. Fogarty International Center
(FIC) for Advanced Study in the Health Sciences, both of the National
Institutes of Health. The supplements also bolstered counts of disease-fighting
immune cells, and modestly lowered HIV levels in the blood.

The study appears in the July 1 New England Journal of Medicine.

"This study provides evidence that multivitamin supplements
may allow women in developing countries who are infected with the
AIDS virus to go for longer than they otherwise would before needing
anti-AIDS drugs," said NICHD Director Duane Alexander, M.D.

"By keeping women healthier longer, multivitamin therapy can
help to assure that anti-HIV drugs can be directed to those who
need them most," said FIC Acting Director Sharon Hrynkow, Ph.D.

The first author of the study was Wafaie Fawzi, associate professor
of nutrition and epidemiology at the Harvard School of Public Health.
Other authors of the study also were from the Harvard School of
Public Health as well as from the Muhimbili University College of
Health Sciences in Dar es Salaam, Tanzania.

The authors conducted the study from 1995 to 2003, a time when the
antiretroviral drugs were not available to most women in Tanzania,
including those who took part in the study.

The researchers enrolled 1,078 HIV-infected pregnant women in Dar
es Salaam, Tanzania. Women were assigned to one of four groups and
received either a placebo, vitamin A, vitamin A in combination with
a multivitamin preparation or a multivitamin preparation alone.
The women took the vitamins during pregnancy and continued taking
them for as long as they participated in the study  more than
5 years, in many cases. The multivitamin preparation contained high
doses of vitamins C, E, and folic acid, as well as the vitamins
in the B complex group (B1, B2, B6, B12, and niacin). All of the
women received folic acid and an iron supplement during pregnancy,
whether they were in the placebo group or the vitamin groups.

All the women received periodic checkups for at least 4 years after
giving birth, and about half of the women received checkups for
more than 5 years after giving birth. The researchers charted the
women's progress to determine whether the supplements had an effect
on the progression of HIV disease to severe symptoms, to AIDS, or
death; or on the levels of certain immune cells (CD4+ and CD8+ cells);
and on levels of HIV in the blood.

In all, 18 of 271 (7 percent) of the women who took multivitamins
progressed to AIDS during the course of the study, compared with
31 among 267 (12 percent) of the women in the placebo group, a 50
percent reduction in the risk of progression to AIDS. Of the 271,
52 (19 percent) of the women who took multivitamins died, compared
with 66 of 267 women (25 percent) in the placebo group. Although
the number of deaths were lower in women receiving multivitamins,
this was not a statistically significant difference. The effect
of multivitamins was strongest in the first 2 years of follow-up.

The women taking multivitamins also had fewer symptoms of later
stage HIV infection, such as mouth infections, mouth ulcers, or
diarrheal diseases, than did women in the other group. Similarly,
the women in the multivitamin group also had significantly higher
CD4+ cell counts than did women in the other groups: overall, the
average CD4+ cell count was 48 cells higher in women who received
multivitamins compared to those who received placebo. The HIV virus
level in the blood was also modestly but significantly lower in
women who received multivitamins.

The women who took vitamin A alone did not show any pronounced differences
from the women in the placebo group, and adding vitamin A to the
multivitamin preparation did not appear to offer any significant
added benefit compared with multivitamins alone.

The benefits noted in the Tanzania trial are modest compared to
the effects of combination antiretroviral therapy, the authors wrote.
In the United States, physicians routinely prescribe multivitamins
to pregnant women. Moreover, in developed countries like the United
States, pregnant women infected with HIV are routinely given a combination
of three or more anti-HIV drugs during pregnancy to prevent the
spread of the virus to their infants.

However, in developing countries, vitamin supplementation during
pregnancy is not routine and is not provided following pregnancy,
explained Lynne Mofenson, M.D., Chief of NICHD's Pediatric, Adolescent
and Maternal AIDS branch, which provided funding for the study.

"These results suggest that use of multivitamins by HIV-infected
women during and after pregnancy can slow the course of HIV disease,
and could provide a low-cost treatment to prolong the time before
they need antiretroviral therapy," Dr. Mofenson said. She added
that multivitamin therapy could result in significant cost savings
for developing countries.

The researchers wrote that the retail costs of a year's supply of
the multivitamins used in this trial is about $15, and that wholesale
prices are substantially lower. "Our findings should encourage
the use of multivitamin supplements as supportive care to those
infected with HIV in developing countries," Dr. Fawzi said.

Dr. Mofenson noted that more studies are needed to define the minimum
dose of multivitamins needed to produce a health benefit and to
determine whether the multivitamins might provide similar benefits
if given to persons already receiving antiretroviral therapy.

The NICHD is part of the National Institutes of Health (NIH),
the biomedical research arm of the federal government. NIH is an
agency of the U.S. Department of Health and Human Services. The
NICHD sponsors research on development, before and after birth;
maternal, child, and family health; reproductive biology and population
issues; and medical rehabilitation. NICHD publications, as well
as information about the Institute, are available from the NICHD
Web site, http://www.nichd.nih.gov,
or from the NICHD Information Resource Center, 1-800-370-2943; e-mail
NICHDInformationResourceCenter@mail.nih.gov.